Sr Clinical Trial Manager

Syneos Health, Inc.; Morrisville (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Sr Clinical Trial Manager in North Carolina. The role involves oversight of site management, clinical monitoring deliverables, and ensuring compliance with regulations. This position requires a Bachelor's degree and offers opportunities for professional development within an international setting. Competitive salary and benefits provided.

Benefits

Career development opportunities

Supportive management

Engaging work culture

Qualifications

• Demonstrated ability to lead teams in achieving project milestones.
• Ability to work in an international environment.
• Understanding of Good Clinical Practice/ICH Guidelines.

Responsibilities

• Responsible for site management oversight and clinical monitoring deliverables.
• Reviews study scope of work, budget and protocol content.
• Employs strategic thinking to propose and implement risk mitigations.

Skills

Leadership

Site management

Problem-solving

Risk management

Critical thinking

Education

Bachelor’s degree or RN in a related field

Job description

Sr Clinical Trial Manager

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity.
• Reviews the study scope of work, budget and protocol content and ensures the clinical project team is aware of the contractual obligations and parameters.
• Employs strategic thinking and problem-solving skills to propose and implement risk mitigations.
• Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members.
• Collaborates with other functional leaders to coordinate delivery handoffs and meet expected study milestones.
• Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan.
• Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form completion, dashboards, Sponsor Standard Operating Procedures, clinical plans and guidelines, data plans and timelines for the study.
• Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality.
• Reviews the project oversight dashboards and other clinical trial systems to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects.
• Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan.
• Reviews the content and quality of site and central monitoring documentation.
• Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables.
• Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations.
• Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance.
• Provides feedback to line managers on staff performance including strengths as well as areas for development.
• May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects.
• May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
• Demonstrated ability to lead and align teams in the achievement of project milestones.
• Demonstrated capability of working in an international environment.
• Demonstrated expertise in site management and monitoring (clinical or central).
• Preferred experience with risk-based monitoring.
• Demonstrates understanding of clinical trial management financial principles and budget management.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Demonstrated ability to apply problem-solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project.
• Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues.
• Moderate travel may be required, approximately 20%.

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.